Bortezomib, FSGS, Glomerulonephritis, IgA Nephropathy, MN, MPGN
Conditions
Brief summary
Bortezomib is a proteasome inhibitor that inhibits autoantibody production, and reduces podocyte damage and mesangial hyperplasia caused by NF-κB activation in the kidney. Literature has reported that bortezomib can achieve a complete response rate of up to 38% in the treatment of glomerular diseases, but its safety and effectiveness remain to be assessed for the Chinese demographic. This study attempts to explore a new treatment plan for glomerular disease by observing the therapeutic effect of bortezomib on glomerular disease.
Interventions
DRUGBortezomib
Dexamethasone 10mg+ bortezomib (1.3mg /m2 IV) was administered at D1,D4,D8,D11, one month for 1 cycle, for 2 cycles.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Glomerular diseases confirmed by renal biopsy (including IgA nephropathy, membranous nephropathy, FSGS, etc.) * Aged 18-65, male or female * Signed informed consent * 24h proteinuria \>1.5g/24h * Glomerular filtration rate (eGFR) \>30ml/min/1.73m2 (calculated according to CKD-EPI formula) within 14 days before enrollment. * Blood pressure \<140/90mmHg after drug treatment * Unless there are contraindications, subjects must take a steady dose of ACEI and/or ARB for at least 4 weeks before screening
Exclusion criteria
* Renal pathology: glomerulosclerosis ratio \>70%, interstitial fibrosis \> severe * Received immunosuppressant treatment within the past 6 months * Inability to tolerate bortezomib * Platelet count \< 30×109/L within 14 days before enrollment * Neutrophil count \< 1.0×109/L within 14 days before enrollment * Subjects had \>grade 2 peripheral neuropathy within 14 days before enrollment * ECG evidence of myocardial infarction or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or acute ischemia or active conduction system abnormalities within 6 months before enrollment * Abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>=3 times normal upper limit (ULN), total bilirubin \>= 2 times ULN * Newly diagnosed malignant tumor (within 5 years) or undergoing radiotherapy/chemotherapy * Women who are pregnant or breast-feeding, or women of childbearing age who cannot guarantee effective contraception * New serious life-threatening infections * Active infectious diseases such as active tuberculosis, active viral hepatitis, HIV infection. * Mental disorders and psychotropic drug uses * Patients with an estimated life expectancy of fewer than 12 months * Patients that were difficult to follow up on or had poor compliance * Patients who do not wish to sign the form of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate of Proteinuria | One Year | 24h Proteinuria \<300mg/24h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Bortezomib | One Year | Incidence of Treatment-Emergent Adverse Events |
Countries
China
Outcome results
None listed